MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW EZ-IO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	IPN033711
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient at outpatient facility became unresponsive.911 called to respond to a patient in cardiac arrest.Staff member went to pts legs to start an easy io on pts left lower leg.The easy io was assembled and drill started.When the staff member withdrew the needle cath it was discovered there was no inner cath.He was unable to connect the iv because there was no ez-connect extension set included.This resulted in removing this from the patient's leg and repeating the process with a new package which included the entire connection set.

• Brand Name: ARROW EZ-IO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 8168830
• Report Number: 8168830
• Device Sequence Number: 1406405
• Product Code: FMI
• UDI-Device Identifier: 00816000011942
• UDI-Public: (01)00816000011942
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/05/2018
• Report Date (Section F): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN033711
• Device Catalogue Number: 9001-VC-005
• Device Lot Number: 6015843
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/05/2018